Cleared Traditional

K854326 - NO FLOSS FLOSSER

K854326 is an FDA 510(k) clearance for NO FLOSS FLOSSER, manufactured by Rgm Assoc.. The device is a Class 1 Dental device with product code JEQ cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K854326 · Rgm Assoc. · Dental device
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Apr 1986
Decision
177d
Days
Class 1
Risk

K854326 is an FDA 510(k) clearance for the NO FLOSS FLOSSER. Classified as Toothbrush, Powered (product code JEQ), Class I - General Controls.

Submitted by Rgm Assoc. (Los Altos, US). The FDA issued a Cleared decision on April 23, 1986 after a review of 177 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6865 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Rgm Assoc. devices

FDA 510(k) Submission Details - K854326

510(k) Number K854326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date April 23, 1986
Days to Decision 177 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 128d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

JEQ Device Classification - Class 1, General Controls

Product Code JEQ Toothbrush, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6865
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.